It's a comparison that can't be made. This is a clinical data driven business/sector. The Genervon data is Phase 2a which is so early that it barely counts. They have many years of research to go before they can even be seen as a viable competitor in the PD field. Definitely not worth worrying about. PDP will be relevant for many years to come as there is nothing on the horizon that is going to cure Parkinson's. Nuplazid is the right drug at the right time. That goes for Alzheimer's as well.
Actually, if you go to AbbVie's website and look at their areas of interest they list CNS as being a definite focus area. More importantly, both Alzheimer's and Parkinson's are highlighted. The other condition highlighted is MS so they only list three CNS conditions. Nuplazid checks off the Parkinson's box and may end up checking off the Alzheimer's box. The potential value of Nuplazid to any large pharma could be astounding if the candidate is fully exploited.
CNS is a focus area for most large pharma groups, but AbbVie has been open about the fact that they're shopping and this is especially highlighted because of their bid for Shire. If the Shire deal doesn't go forward AbbVie will be on the hook for a $1.6 billion break-up fee. That's a lot! You can bet that AbbVie's management will be shopping aggressively for US collaborations to show shareholders a better option than Shire.
I am of course a believer than Acadia will eventually be acquired in an M&A deal and I believe that current circumstances increase the chances that a buyout would happen before drug launch.
Up 9.75% on a day like today. Something may be up. Let's see what the rest of the week brings.
Pure speculation on my part and many of you know that I believe Acadia will have an exit via M&A with contingency value rights attached. I know biotechs are rebounding today, but I found it interesting that Acadia in particular is rebounding so drastically. Just makes me wonder if perhaps Abbvie or Shire were potential partners at one time. We shall see...
Well you made me laugh with that one.
Couldn't agree with you more. In under 2.5 months the NDA will be filed. Within two months after that we'll likely have a Priority Review. Things get really interesting at that point. I still believe potential buyers are circling. All pharma needs drugs and CNS is on the shopping list of almost all major pharma groups.
Well, all I can say is that I bought hand over fist when it last cracked $15. I don't think I would be shy this time either. Let's see...Acadia is down a good amount but it's holding up better than some others.
I think the bet is that the market is correcting and companies like Acadia will take a disproportionately large hit. However, what the shorts likely don't understand is that Acadia is probably on the radars of companies looking at M&A. I'm not sure how things will unfold, but I do know that the shorts will get crushed if an M&A happens or if they hold their short positions for too long. I know many longs here are against M&A because they can't see a $40-50 price being fair (even with CVRs). However, I think longs would chuckle if an offer came in that suddenly propelled the stock to $40/50 as the shorts would be properly roasted.
I agree with you. Hedge funds or market conditions....the NDA is about to be filed for a blockbuster candidate and M&A is on fire in pharma/biotech land. It's a good time to own Acadia IMO.
I definitely can see it happening. The way to fully value Acadia is to attach CVRs or contingent value rights to the deal. If Nuplazid pans out in ADP or schiz the CVRs would allow for more upside to go to shareholder of record at the time of the close of the transaction. I'm being a bit simplistic, but you can see how I'm thinking about this.
Roche bought Intermune for over $8 billion. Acadia's valuation is under $2.4 billion. If a pharma company puts down $5B I can see a deal happening. The environment for M&A is super hot and there is no way around the fact that Acadia is sitting on a blockbuster and Acadia is undervalued. If I'm a large pharma interested in CNS I'm looking at Acadia.
Teva announced that they're going to drop 14 programs and will focus heavily on CNS and respiratory going forward. Acadia has to be on their radar big time.
Definitely business as usual. Acadia does not update shareholders very often, but they have always been very consistent with the data they do share. The update I would watch for is the filing of the NDA and also any additional trial launches in conditions such as schizophrenia.
It would be nice to hear some encouraging words, but they're frankly not necessary. The next major milestone is the filing of the NDA and all statements from the company indicate that this will take place around year end. The clock is ticking on the NDA filing and a Priority Review which in my opinion will be granted. Regardless of the stock fall, the date for the NDA filing is getting close. It's within this quarter. Acadia will not be in the shadows once the filing happens.
I know what you're saying about $10-15B, but I don't think Acadia can demand that kind of premium until we have ADP data and it's very positive. Positive data in ADP is not yet an absolute so I want to be a little careful in terms of how much value I assign to that indication. I definitely agree that it should be positive, but I want to avoid assuming that it's a definite. Also, contingent value rights could address your concern so that we can see more upside if ADP pans out.
What would you think about a joint venture where a large pharma becomes a large shareholder and co-markets/co-promotes with Acadia?
I personally believe that a JV or tie-up between Allergan and Acadia makes sense. Allergan is of course fighting off a bid from Valeant at the moment. Part of Allergan's strategy to avoid a deal with Valeant is to build shareholder value through M&A with other outfits. As has recently become clear, they are no longer in talks with Salix which may mean that they have decided to build the next phase of the company around a blockbuster drug candidate and pipeline that can compliment what Allergan is already doing.
JPM recently discussed that Acadia would be targeting long term nursing homes right out of the gate with Nuplazid. The aging population guarantees that there is a huge potential market for Nuplazid in nursing homes where it’s sometimes very difficult to tell the difference between ADP, psychosis related to stroke or some other dementia. The fact is that the picture is often mixed. Many of these patients are put on an atypical antipsychotic such as risperidone even though these patients cannot tolerate these meds. Imagine an eventual Nuplazid label that allows for the broad treatment of psychotic illnesses in the elderly. Nuplazid could quite literally take the entire market. Factor in that Nuplazid helps sleep quality, a huge problem in nursing home patients, and you can see that many nursing home patients could benefit from Nuplazid. This is in addition to the market that will also exist outside of nursing homes which is also likely to be significant.
Where do I see synergy with Allergan? Think about conditions impacting nursing home patients. Top conditions would include Alzheimer’s (Nuplazid), urinary incontinence (Botox), ophthalmic conditions such as dry eye and AMD (Allergan), sleep quality related to psychosis or CNS disease (Nuplazid). In addition, patients with CNS disorders can have issues with involuntary muscle movements (Botox).
This is pure speculation on my part, but I can see M&A between Allergan and Acadia.
To be honest, this looks like a passive aggressive hit piece. To say that sales "could" be higher with positive ADP data is just funny. Of course they would be higher and way way higher.
Also, this author talks up delays in the NDA filing. The delay was baked in long ago as this NDA filing wasn't rushed in the least. If anything it has been delayed as to make sure all bases were covered.
There is no talk of breakthrough therapy designation which definitely increases the chances of getting to market rapidly upon NDA filing. There is also no talk off obvious off-label use in other CNS indications.
Finally, there is no talk of M&A when the entire sector is on fire and Acadia is obviously sitting on a potential blockbuster candidate so they're clearly in play.
I think this piece was designed to create uncertainty around the NDA timeline and the overall potential of Pimavansin. Most of these authors are jokes. Let's be real about it.
I agree. It seems like the main rate limiting step at this stage is how quickly Acadia can move. I would love an October NDA filing.
Thanks for pointing this out. The emphasis on psychiatrists really encourages me. It tells me that in addition to ADP and PDP, they are going to focus seriously on schizophrenia and perhaps bipolar. I laugh when I read analysts talk about too much competition in schizophrenia due to so many generic agents. It's obvious none of these people have credentials in CNS because the existing drugs are nightmarish. The side effects are terrible for patients. Pimavanserin has so much potential. If Acadia can produce good data in schizophrenia and bipolar my personal opinion is that a huge market will be waiting for Pima.
Am I the only investor following this company? UniQure reminds me of BlueBird and I think that it has similar potential. I'm buying shares on weakness. Is anyone else out there following this story? Superb team and superb science.